FDA 510(k)

瑞士移植X

K 號：K251613 · 2025-06-26

決定日期2025-06-26

產品代碼NPM

諮詢委員會DE

決定相當於

器材摘要

SwissGraft X is the device name listed in this FDA 510(k) record. The listed applicant is Geistlich Pharma AG. It received FDA 510(k) clearance on 2025-06-26 under 510(k) number K251613. The device is classified under product code NPM. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SwissGraft X?

SwissGraft X is a medical device that received FDA 510(k) clearance on 2025-06-26. The listed applicant is Geistlich Pharma AG. The 510(k) number is K251613.

When did SwissGraft X receive FDA 510(k) clearance?

SwissGraft X received FDA 510(k) clearance on 2025-06-26, under 510(k) number K251613.

Who is the listed applicant for SwissGraft X?

The FDA 510(k) record lists Geistlich Pharma AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SwissGraft X?

The FDA product code for SwissGraft X is NPM.

其他以 Geistlich Pharma AG 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K260364設備 300419 識別條 K260532德瑪吉德 K251323設備 104 粒子 K252253Geistlich Mucograft® /Geistlich Mucograft® 密封劑；Geistlich Fibro-Gide®K251062Geistlich Bio-Gide；Geistlich Bio-Gide® Shape；Geistlich Bio-Gide® Compressed；Geistlich Bio-Gide® Forte；Geistlich Bio-Gide® Perio；Geistlich Combi-Kit Collagen®；Geistlich Perio-System Combi Pack K251556設備 300423 粉末

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相關器械（代碼：NPM）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K254210REBOHIL（BGM-1、BGM-2、BGM-3、BGM-4、BGM-5）Hyundai Bioland Co., Ltd.K253723BOSSMedpark Co., Ltd.K251786Geistlich Bio-Oss®；Geistlich Bio-Oss Pen®Geistlich Pharma AG K242510Geistlich 生物流®Geistlich Pharma AG K240133異種移植牛骨微粒Collagen Solutions, LLC K230305植皮膠原蛋白Purgo Biologics, Inc.

官方來源

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